The present invention relates to a disposable cincture and a method for stabilizing, securing and otherwise holding biomedical tubing such as endo-, naso-tracheal, and esophageal tubes, and the like.
Traditionally when patients, who require ventilatory support or gastro-intestinal intervention are intubated with a tracheal or esophogeal tube, either orally or nasally, the tube is secured or stabilized to prevent accidental extubation by taping it to the patient's face with adhesive tape. Alternatively, currently available commercial tube holders, most of which use straps, adhesives, or a combination thereof, are used to anchor the tubes to the patient's face.
Most biomedical tube holding devices are either cumbersome, restricted to holding a specific or narrow range of tube types, rely heavily on adhesives, or are uncomfortable and often expensive.
Reliable methods of securing biomedical tubes are of critical importance to patient safety particularly with the use of endotracheal tubes. Intra-operatively, endotracheal tubes are used to provide ventilatory support for patients undergoing surgery under general anesthesia. Since the patients cannot breath for themselves, a dislodged endotracheal tube would interfere with ventilation resulting in death or severe brain injury due to a lack of oxygen. In emergency medical service, where patients may require ventilatory support following trauma, poisoning, drowning, etc., survival depends on a reliably secure airway. These patients can be conscious, and are often combative, requiring the endotracheal tube stabilizing device to be all the more reliable. Moisture accumulation from exhaled air, saliva and other secretions can quickly saturate the endotracheal securing means causing the potential for slippage and subsequent dislodging of the endotracheal tube.
Currently, the preferred method of securing biomedical tubes, such as the endotracheal tube, is to circumferentially wrap adhesive tape around the exposed portion of the tube followed by attachment of the tape to the facial area surrounding the insertion point. While this approach provides a reasonably reliable means for securing the endotracheal tube, it is not without significant drawbacks. Health care providers, as a general rule, have begun wearing latex or plastic examination gloves in order to minimize the potential for coming in contact with bacterial and viral agents that can be life threatening. The smooth uniform surface of latex and plastic examination gloves provides a surface to which adhesive tape sticks tenaciously, often causing the gloves to tear while attempting to disengage from the tape. Additionally, this adhesive tenacity can cause great difficulty in handling and applying the tape when wearing plastic or latex gloves such that the process of securing the endotracheal tube can be prolonged or altogether confounded. The presence of facial hair, such as beards and/or moustaches, makes securing the endotracheal tube almost impossible.
Currently available commercial alternatives are themselves not without significant drawbacks. A device described by Wapner U.S. Pat. No. 4,548,200 comprised of a short strip of Velcro type material having a dense array of hooks and an adhesive back is circumferentially wrapped around the exposed portion of the endotracheal tube. A band of soft material having a dense array of loops for engaging the Velcro hooks is wrapped around the Velcro adhering to the tube, with the opposing ends encircling the head. Velcro tabs with hooks attach the ends to the encircling portions of the bands after criss-crossing behind the head. While initially providing secure fixation of the endotracheal tube, accumulating moisture neutralizes the adhesion between the tube and circumferentially attached Velcro hook strip as well as saturating the soft band. Because the Velcro strip is no longer held securely, and adhesion to the tube is lost, the Velcro strip often slips down into the patient's mouth posing both the threat of extubation and ingestion or inhalation of a foriegn body. Other shortcomings of this device are that the patient's head must be lifted in order to encircle and secure the bands. The tab of Velcro hooks which are affixed to the tube can also obscure depth gradations making assesement of proper tube position difficult. Application of the adhesive backed tab of Velcro hooks while wearing protective gloves can be plagued by the same problems as experienced with tape.
Another device, identified as the "Tube Restraint", which has avoided the use of adhesives is that disclosed by Shattuck (U.S. Pat. No. 4,622,034). This device consists of two flexible strips, one of resilient polyester foam and the other of nylon tricot having a porous side and a smooth side, laminated into a single piece. At one end of the strip is a 23/4 inch slit and at the opposite end is a tab of Velcro hooks. Since the slit evolves from dividing the strip longitudinally into two sections, the tensile strength of the resulting sections is reduced by half and may, therefore, be subject to failure under extreme stress such as can be imposed by combative patients struggling to dislodge the endotracheal tube from their trachea. Further, by dividing the foam strip into two portions the narrower sections become more susceptible to stretching and absorption of saliva resulting in a diminution of the grip on the tube.
Carrol discloses yet another variation on this art,(U.S. Pat. No. 4,844,061). An adhesive strip permanently affixed to the end of an elongated strip similar to that disclosed by Shattuck is circumferentially adhered to a portion of the endotracheal tube protruding from the mouth of a patient. The opposing end encircles the head, and is wrapped around the tube attaching to the encircling band by a tab of Velcro hooks. This embodiment suffers from the same drawbacks as the devices disclosed by Wapner and Shattuck, in that moisture from saliva can neutralize the adhesion between tube and the adhesive strip, the adhesive strip can stick to protective gloves, and the tensile strength of the adhesive strip may be insufficient to adequately tighten the elongated strap so as to create a reliably secure fixation of the tube.
Health care providers require that biomedical tube holders reliably fixate biomedical tubes without the use of adhesives, can be applied quickly and simply, are disposable, comfortable for the patient, and are available at the lowest possible cost.
The purpose of the Biomedical Tube Holding device is to safely, securely, and reliably secure or fixate a biomedical tube. It is the intent and object of the Biomedical Tube Holding device to provide a holder that does not use skin adhering adhesives or foam strips with slits that may weaken and tear apart under extreme stress and cause the tube to dislodge. It is a further object of this invention to accommodate patients of any size, with comfort. In addition, the device is removable, re-applicable, sterilizable, and disposable.